Home GUDID 00815362024966 Reform POCT System
Primary DI 00815362024966
Brand Reform POCT System
Company PRECISION SPINE, INC.
Model 55-OS-4516
Catalog number 55-OS-4516
Device description Ø4.50 x 16mm Occipital Screw
Published 2019-05-06
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name NKG Posterior Cervical Screw System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NKG Posterior Cervical Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00815362024966 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00815362024966 00815362024966 815362024966 0815362024966
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system, non-sterile An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 079398589 Device count 1 DM exempt true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00840019904650 Slimplicity Anterior Cervical Plate System ACP118 ACP118 2019-04-11 00840019904667 Slimplicity Anterior Cervical Plate System ACP120 ACP120 2019-04-11 00840019904674 Slimplicity Anterior Cervical Plate System ACP122 ACP122 2019-04-11 00840019904681 Slimplicity Anterior Cervical Plate System ACP124 ACP124 2019-04-11 00840019904698 Slimplicity Anterior Cervical Plate System ACP126 ACP126 2019-04-11 00840019904704 Slimplicity Anterior Cervical Plate System ACP128 ACP128 2019-04-11 00815362021446 Slimplicity Anterior Cervical Plate System 08-9020 08-9020 2019-04-01 00815362021453 Slimplicity Anterior Cervical Plate System 08-9021 08-9021 2019-04-01 00815362021460 Slimplicity Anterior Cervical Plate System 08-9024 08-9024 2019-04-01 00815362021477 Slimplicity Anterior Cervical Plate System 08-9025 08-9025 2019-04-01 00815362021484 Slimplicity Anterior Cervical Plate System 08-9026 08-9026 2019-04-01 00815362021729 Slimplicity Anterior Cervical Plate System 50-0018 50-0018 2019-04-01 00815362021088 Slimplicity Anterior Cervical Plate System 08-0112 08-0112 2019-03-29 00815362021118 Slimplicity Anterior Cervical Plate System 08-0118 08-0118 2019-03-29 00815362021125 Slimplicity Anterior Cervical Plate System 08-0120 08-0120 2019-03-29 00815362021132 Slimplicity Anterior Cervical Plate System 08-0122 08-0122 2019-03-29 00815362021149 Slimplicity Anterior Cervical Plate System 08-0124 08-0124 2019-03-29 00815362021156 Slimplicity Anterior Cervical Plate System 08-0126 08-0126 2019-03-29 00815362021163 Slimplicity Anterior Cervical Plate System 08-0128 08-0128 2019-03-29 00815362021170 Slimplicity Anterior Cervical Plate System 08-0226 08-0226 2019-03-29
Other Devices Sharing Product Codes#